Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,688
|
17,132
|
13,110
|
22,949
|
115
|
149
|
8.77
|
6.49
|
1.43
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
187
|
209
|
312
|
753
|
937
|
2,177
|
|
Comparator
|
2
|
207
|
235
|
344
|
826
|
1,030
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,688
|
17,132
|
13,107
|
22,933
|
99
|
184
|
7.55
|
8.02
|
1.41
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
188
|
209
|
312
|
752
|
935
|
2,177
|
|
Comparator
|
5
|
207
|
235
|
343
|
824
|
1,029
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
7,658
|
7,658
|
20,963
|
20,704
|
195
|
175
|
9.30
|
8.45
|
1.34
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
202
|
474
|
969
|
1,731
|
1,862
|
2,188
|
|
Comparator
|
11
|
196
|
458
|
936
|
1,712
|
1,847
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
7,658
|
7,658
|
20,992
|
20,643
|
176
|
198
|
8.38
|
9.59
|
1.34
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
202
|
475
|
972
|
1,733
|
1,863
|
2,188
|
|
Comparator
|
8
|
194
|
453
|
935
|
1,710
|
1,840
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
7,660
|
7,660
|
9,627
|
9,363
|
64
|
73
|
6.65
|
7.80
|
1.61
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
14
|
203
|
209
|
315
|
774
|
976
|
2,177
|
|
Comparator
|
8
|
182
|
220
|
322
|
741
|
916
|
2,184
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
7,660
|
7,660
|
9,638
|
9,359
|
74
|
73
|
7.68
|
7.80
|
1.59
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
203
|
209
|
315
|
775
|
976
|
2,177
|
|
Comparator
|
2
|
182
|
221
|
322
|
742
|
914
|
2,184
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,688
|
17,132
|
28,205
|
54,618
|
265
|
454
|
9.40
|
8.31
|
1.24
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
188
|
445
|
907
|
1,697
|
1,833
|
2,189
|
|
Comparator
|
5
|
265
|
614
|
1,221
|
1,911
|
2,029
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,688
|
17,132
|
28,176
|
54,714
|
277
|
421
|
9.83
|
7.69
|
1.24
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
188
|
441
|
902
|
1,698
|
1,833
|
2,189
|
|
Comparator
|
2
|
270
|
620
|
1,222
|
1,911
|
2,029
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
7,665
|
7,665
|
9,649
|
9,282
|
78
|
67
|
8.08
|
7.22
|
1.59
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
201
|
209
|
315
|
777
|
975
|
2,177
|
|
Comparator
|
9
|
181
|
222
|
320
|
732
|
897
|
2,177
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
7,665
|
7,665
|
9,638
|
9,275
|
70
|
81
|
7.26
|
8.73
|
1.58
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
201
|
209
|
315
|
776
|
972
|
2,177
|
|
Comparator
|
5
|
180
|
220
|
319
|
731
|
898
|
2,177
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,688
|
17,132
|
13,110
|
22,949
|
115
|
149
|
8.77
|
6.49
|
1.43
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
187
|
209
|
312
|
753
|
937
|
2,177
|
|
Comparator
|
2
|
207
|
235
|
344
|
826
|
1,030
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,688
|
17,132
|
13,107
|
22,933
|
99
|
184
|
7.55
|
8.02
|
1.41
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
188
|
209
|
312
|
752
|
935
|
2,177
|
|
Comparator
|
5
|
207
|
235
|
343
|
824
|
1,029
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
7,667
|
7,667
|
21,155
|
20,635
|
193
|
178
|
9.12
|
8.63
|
1.34
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
209
|
480
|
984
|
1,733
|
1,862
|
2,188
|
|
Comparator
|
11
|
193
|
452
|
935
|
1,707
|
1,841
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
7,667
|
7,667
|
21,158
|
20,602
|
191
|
192
|
9.03
|
9.32
|
1.33
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
209
|
481
|
986
|
1,733
|
1,862
|
2,188
|
|
Comparator
|
5
|
191
|
448
|
934
|
1,708
|
1,841
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,688
|
17,132
|
28,176
|
54,714
|
277
|
421
|
9.83
|
7.69
|
1.24
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
188
|
441
|
902
|
1,698
|
1,833
|
2,189
|
|
Comparator
|
2
|
270
|
620
|
1,222
|
1,911
|
2,029
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,688
|
17,132
|
28,205
|
54,618
|
265
|
454
|
9.40
|
8.31
|
1.24
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
188
|
445
|
907
|
1,697
|
1,833
|
2,189
|
|
Comparator
|
5
|
265
|
614
|
1,221
|
1,911
|
2,029
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Etanercept (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Etanercept (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,454
|
20,386
|
12,847
|
25,958
|
117
|
183
|
9.11
|
7.05
|
1.41
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
188
|
209
|
312
|
754
|
943
|
2,177
|
|
Comparator
|
4
|
207
|
232
|
333
|
777
|
970
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,454
|
20,386
|
12,850
|
25,924
|
97
|
189
|
7.55
|
7.29
|
1.42
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
189
|
209
|
312
|
754
|
941
|
2,177
|
|
Comparator
|
2
|
207
|
232
|
332
|
776
|
969
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
8,216
|
8,216
|
22,084
|
21,878
|
213
|
203
|
9.64
|
9.28
|
1.32
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
196
|
462
|
931
|
1,711
|
1,848
|
2,188
|
|
Comparator
|
4
|
180
|
441
|
931
|
1,693
|
1,838
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
8,216
|
8,216
|
22,112
|
21,879
|
200
|
193
|
9.04
|
8.82
|
1.33
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
199
|
466
|
937
|
1,707
|
1,846
|
2,188
|
|
Comparator
|
2
|
182
|
441
|
928
|
1,695
|
1,840
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
8,210
|
8,210
|
10,198
|
9,704
|
93
|
82
|
9.12
|
8.45
|
1.53
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
194
|
209
|
315
|
770
|
950
|
2,177
|
|
Comparator
|
4
|
174
|
212
|
312
|
707
|
878
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
8,210
|
8,210
|
10,203
|
9,684
|
75
|
82
|
7.35
|
8.47
|
1.56
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
194
|
209
|
314
|
770
|
949
|
2,177
|
|
Comparator
|
2
|
174
|
212
|
312
|
706
|
877
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,454
|
20,386
|
27,779
|
60,382
|
276
|
455
|
9.94
|
7.54
|
1.24
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
189
|
447
|
915
|
1,705
|
1,838
|
2,189
|
|
Comparator
|
4
|
231
|
550
|
1,098
|
1,797
|
1,952
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,454
|
20,386
|
27,803
|
60,337
|
263
|
449
|
9.46
|
7.44
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
192
|
451
|
920
|
1,704
|
1,838
|
2,189
|
|
Comparator
|
2
|
230
|
547
|
1,097
|
1,798
|
1,952
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
8,210
|
8,210
|
10,153
|
9,644
|
78
|
79
|
7.68
|
8.19
|
1.56
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
195
|
209
|
313
|
761
|
946
|
2,177
|
|
Comparator
|
15
|
179
|
213
|
313
|
706
|
874
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
8,210
|
8,210
|
10,153
|
9,649
|
88
|
88
|
8.67
|
9.12
|
1.53
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
195
|
209
|
313
|
762
|
946
|
2,177
|
|
Comparator
|
4
|
175
|
213
|
313
|
707
|
876
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,454
|
20,386
|
12,847
|
25,958
|
117
|
183
|
9.11
|
7.05
|
1.41
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
188
|
209
|
312
|
754
|
943
|
2,177
|
|
Comparator
|
4
|
207
|
232
|
333
|
777
|
970
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,454
|
20,386
|
12,850
|
25,924
|
97
|
189
|
7.55
|
7.29
|
1.42
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
189
|
209
|
312
|
754
|
941
|
2,177
|
|
Comparator
|
2
|
207
|
232
|
332
|
776
|
969
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
8,211
|
8,211
|
22,105
|
22,110
|
214
|
186
|
9.68
|
8.41
|
1.32
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
199
|
461
|
938
|
1,712
|
1,845
|
2,188
|
|
Comparator
|
4
|
180
|
447
|
944
|
1,715
|
1,858
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
8,211
|
8,211
|
22,134
|
22,086
|
203
|
182
|
9.17
|
8.24
|
1.33
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
200
|
464
|
942
|
1,712
|
1,845
|
2,188
|
|
Comparator
|
7
|
179
|
446
|
942
|
1,718
|
1,861
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,454
|
20,386
|
27,779
|
60,382
|
276
|
455
|
9.94
|
7.54
|
1.24
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
189
|
447
|
915
|
1,705
|
1,838
|
2,189
|
|
Comparator
|
4
|
231
|
550
|
1,098
|
1,797
|
1,952
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
10,454
|
20,386
|
27,803
|
60,337
|
263
|
449
|
9.46
|
7.44
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
10
|
192
|
451
|
920
|
1,704
|
1,838
|
2,189
|
|
Comparator
|
2
|
230
|
547
|
1,097
|
1,798
|
1,952
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RCT)) and
comparator (
Adalimumab (RCT)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RCT)) and comparator (
Adalimumab (RCT)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,961
|
71,261
|
43,059
|
97,478
|
286
|
412
|
6.64
|
4.23
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
186
|
209
|
313
|
753
|
943
|
2,189
|
|
Comparator
|
2
|
207
|
235
|
348
|
848
|
1,062
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,961
|
71,261
|
43,042
|
97,443
|
265
|
453
|
6.16
|
4.65
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
186
|
209
|
313
|
753
|
943
|
2,189
|
|
Comparator
|
1
|
207
|
235
|
348
|
849
|
1,062
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
26,474
|
26,474
|
74,886
|
72,547
|
506
|
506
|
6.76
|
6.97
|
1.19
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
195
|
476
|
1,025
|
1,791
|
1,915
|
2,190
|
|
Comparator
|
2
|
165
|
447
|
963
|
1,748
|
1,908
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
26,474
|
26,474
|
74,886
|
72,520
|
497
|
483
|
6.64
|
6.66
|
1.20
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
196
|
476
|
1,025
|
1,788
|
1,914
|
2,190
|
|
Comparator
|
2
|
165
|
446
|
963
|
1,748
|
1,909
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
26,465
|
26,465
|
32,899
|
32,099
|
203
|
180
|
6.17
|
5.61
|
1.33
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
192
|
209
|
313
|
761
|
959
|
2,189
|
|
Comparator
|
2
|
167
|
209
|
317
|
736
|
912
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
26,465
|
26,465
|
32,891
|
32,075
|
187
|
197
|
5.69
|
6.14
|
1.33
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
192
|
209
|
313
|
761
|
961
|
2,189
|
|
Comparator
|
2
|
166
|
209
|
316
|
735
|
914
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,961
|
71,261
|
96,598
|
239,487
|
699
|
1,196
|
7.24
|
4.99
|
1.15
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
187
|
459
|
979
|
1,767
|
1,896
|
2,190
|
|
Comparator
|
2
|
273
|
668
|
1,309
|
1,994
|
2,091
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,961
|
71,261
|
96,529
|
239,321
|
686
|
1,188
|
7.11
|
4.96
|
1.15
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
187
|
459
|
978
|
1,763
|
1,895
|
2,190
|
|
Comparator
|
1
|
272
|
665
|
1,308
|
1,995
|
2,091
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
26,450
|
26,450
|
32,793
|
31,940
|
189
|
202
|
5.76
|
6.32
|
1.33
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
193
|
209
|
313
|
756
|
953
|
2,189
|
|
Comparator
|
2
|
165
|
209
|
317
|
733
|
906
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
26,450
|
26,450
|
32,799
|
31,969
|
202
|
184
|
6.16
|
5.76
|
1.33
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
193
|
209
|
314
|
756
|
953
|
2,189
|
|
Comparator
|
2
|
166
|
209
|
317
|
733
|
906
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,961
|
71,261
|
43,059
|
97,478
|
286
|
412
|
6.64
|
4.23
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
186
|
209
|
313
|
753
|
943
|
2,189
|
|
Comparator
|
2
|
207
|
235
|
348
|
848
|
1,062
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,961
|
71,261
|
43,042
|
97,443
|
265
|
453
|
6.16
|
4.65
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
186
|
209
|
313
|
753
|
943
|
2,189
|
|
Comparator
|
1
|
207
|
235
|
348
|
849
|
1,062
|
2,189
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
26,459
|
26,459
|
74,875
|
72,553
|
507
|
491
|
6.77
|
6.77
|
1.19
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
196
|
479
|
1,026
|
1,785
|
1,911
|
2,190
|
|
Comparator
|
2
|
166
|
441
|
966
|
1,743
|
1,909
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
26,459
|
26,459
|
74,906
|
72,644
|
512
|
504
|
6.84
|
6.94
|
1.19
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
195
|
479
|
1,026
|
1,789
|
1,915
|
2,190
|
|
Comparator
|
2
|
166
|
445
|
968
|
1,746
|
1,910
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,961
|
71,261
|
96,598
|
239,487
|
699
|
1,196
|
7.24
|
4.99
|
1.15
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
187
|
459
|
979
|
1,767
|
1,896
|
2,190
|
|
Comparator
|
2
|
273
|
668
|
1,309
|
1,994
|
2,091
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,961
|
71,261
|
96,529
|
239,321
|
686
|
1,188
|
7.11
|
4.96
|
1.15
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
187
|
459
|
978
|
1,763
|
1,895
|
2,190
|
|
Comparator
|
1
|
272
|
665
|
1,308
|
1,995
|
2,091
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
[TOFA]_RWD_ETN_0208version) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
[TOFA]_RWD_ETN_0208version) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,087
|
84,210
|
42,037
|
107,815
|
279
|
475
|
6.64
|
4.41
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
189
|
209
|
313
|
753
|
943
|
2,189
|
|
Comparator
|
1
|
207
|
235
|
335
|
771
|
966
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,087
|
84,210
|
42,027
|
107,767
|
254
|
499
|
6.04
|
4.63
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
2
|
189
|
209
|
313
|
753
|
943
|
2,189
|
|
Comparator
|
2
|
207
|
235
|
335
|
770
|
966
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
27,388
|
27,388
|
76,492
|
75,418
|
516
|
541
|
6.75
|
7.17
|
1.19
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
192
|
466
|
1,001
|
1,776
|
1,904
|
2,190
|
|
Comparator
|
1
|
167
|
444
|
976
|
1,761
|
1,917
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
27,388
|
27,388
|
76,437
|
75,430
|
509
|
513
|
6.66
|
6.80
|
1.19
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
2
|
192
|
466
|
1,000
|
1,775
|
1,903
|
2,190
|
|
Comparator
|
3
|
167
|
444
|
976
|
1,760
|
1,916
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
27,393
|
27,393
|
33,761
|
32,370
|
215
|
205
|
6.37
|
6.33
|
1.31
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
189
|
209
|
312
|
753
|
945
|
2,189
|
|
Comparator
|
1
|
173
|
222
|
316
|
702
|
865
|
2,188
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
27,393
|
27,393
|
33,764
|
32,350
|
186
|
213
|
5.51
|
6.58
|
1.32
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
2
|
190
|
209
|
312
|
753
|
946
|
2,189
|
|
Comparator
|
2
|
173
|
222
|
315
|
701
|
865
|
2,188
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,087
|
84,210
|
94,965
|
259,322
|
690
|
1,259
|
7.27
|
4.85
|
1.15
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
192
|
465
|
991
|
1,775
|
1,904
|
2,190
|
|
Comparator
|
1
|
240
|
577
|
1,169
|
1,876
|
2,005
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,087
|
84,210
|
94,899
|
259,223
|
671
|
1,253
|
7.07
|
4.83
|
1.15
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
2
|
192
|
465
|
991
|
1,771
|
1,903
|
2,190
|
|
Comparator
|
2
|
238
|
574
|
1,169
|
1,876
|
2,005
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
27,372
|
27,372
|
33,741
|
32,278
|
184
|
213
|
5.45
|
6.60
|
1.32
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
6
|
193
|
209
|
312
|
753
|
945
|
2,189
|
|
Comparator
|
3
|
172
|
221
|
315
|
701
|
871
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
27,372
|
27,372
|
33,739
|
32,306
|
203
|
204
|
6.02
|
6.31
|
1.32
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
193
|
209
|
312
|
753
|
945
|
2,189
|
|
Comparator
|
1
|
172
|
221
|
315
|
702
|
872
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,087
|
84,210
|
42,037
|
107,815
|
279
|
475
|
6.64
|
4.41
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
189
|
209
|
313
|
753
|
943
|
2,189
|
|
Comparator
|
1
|
207
|
235
|
335
|
771
|
966
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,087
|
84,210
|
42,027
|
107,767
|
254
|
499
|
6.04
|
4.63
|
1.25
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
2
|
189
|
209
|
313
|
753
|
943
|
2,189
|
|
Comparator
|
2
|
207
|
235
|
335
|
770
|
966
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
27,372
|
27,372
|
76,466
|
75,012
|
513
|
515
|
6.71
|
6.87
|
1.19
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
6
|
194
|
468
|
1,001
|
1,771
|
1,902
|
2,190
|
|
Comparator
|
3
|
173
|
445
|
966
|
1,749
|
1,904
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
27,372
|
27,372
|
76,508
|
75,102
|
511
|
514
|
6.68
|
6.84
|
1.19
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
194
|
468
|
1,004
|
1,775
|
1,903
|
2,190
|
|
Comparator
|
1
|
173
|
445
|
969
|
1,753
|
1,907
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,087
|
84,210
|
94,965
|
259,322
|
690
|
1,259
|
7.27
|
4.85
|
1.15
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
1
|
192
|
465
|
991
|
1,775
|
1,904
|
2,190
|
|
Comparator
|
1
|
240
|
577
|
1,169
|
1,876
|
2,005
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier
Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]
Power
|
Target subjects
|
Comparator subjects
|
Target years
|
Comparator years
|
Target events
|
Comparator events
|
Target IR (per 1,000 PY)
|
Comparator IR (per 1,000 PY)
|
MDRR
|
|
34,087
|
84,210
|
94,899
|
259,223
|
671
|
1,253
|
7.07
|
4.83
|
1.15
|
Table 1a. Number of subjects, follow-up time (in years), number of outcome
events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR).
Note that the IR does not account for any stratification.
|
Cohort
|
Min
|
P10
|
P25
|
Median
|
P75
|
P90
|
Max
|
|
Target
|
2
|
192
|
465
|
991
|
1,771
|
1,903
|
2,190
|
|
Comparator
|
2
|
238
|
574
|
1,169
|
1,876
|
2,005
|
2,190
|
Table 1b. Time (days) at risk distribution expressed as
minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target
(
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) cohort after propensity score adjustment.
Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (
Tofacitinib (RWD)) and
comparator (
Adalimumab (RWD)) group after various stages in the analysis.
Population Characteristics
Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted)
percentage of subjects with the characteristics in the target (
Tofacitinib (RWD)) and comparator (
Adalimumab (RWD)) group, as
well as the standardized difference of the means.
Propensity Scores

Figure 2.
Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.
Covariate Balance

Systematic Error

Figure 4.
Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.
Kaplan-Meier